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SUZHOU, China and ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that its licensee, UNITY Biotechnology ("UNITY", NASDAQ:UBX), has dosed the first patient in a Phase I clinical study of drug candidate UBX1325 in patients with diabetic macular edema (DME). UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. The milestone payment was made in common stocks from UNITY, totaling 228,310 shares.
As UNITY reported in its press release, this "Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME. The trial is designed to enroll approximately 15 patients, with safety and tolerability data expected in the first half of 2021". According to information disclosed by UNITY, preclinical tests have shown UBX1325 leads to an impact on senescent cells, reduction in vascular leakage, and improvement in retinal function.
In 2016, Ascentage Pharma and UNITY entered into a strategic licensing arrangement, authorizing UNITY to screen Ascentage Pharma's Bcl-2 compound library for developing treatments for age-related diseases. The compound BM-962 was selected by UNITY from Ascentage Pharma's library and subject to license agreement between Ascentage Pharma and UNITY. Under the applicable agreements, Ascentage Pharma retains the rights to the compounds in the Greater China region and plans to establish a joint venture with UNITY in the future for the development and commercialization of the compound in China.
UNITY is a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging. As a leader in the field, UNITY was listed on the NASDAQ stock exchange in 2018.
"Dosing the first patient with UBX1325 marks an important milestone in our collaboration with UNITY," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "We look forward to further progresses by UNITY in its clinical development program. We are confident that our collaboration in developing therapies for age-related diseases will bring fresh hope to patients around the world."
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK.
Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, and China. HQP1351, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and a New Drug Application (NDA) for the drug candidate has been submitted in China. To date, Ascentage Pharma has obtained a total of eight ODDs from the US FDA for four of the company's investigational drug candidates.
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